Clinical trials: Leg Injuries and Disorders
Rheumatoid Arthritis, Osteoarthritis
G7 BiSpherical Acetabular Shell PMCF Study
The primary objective of this study is to obtain implant survivorship and clinical outcomes data for the commercially available G7 BiSpherical Acetabular Shell.
- Conditions
- Rheumatoid Arthritis, Osteoarthritis, Noninflammatory Degenerative Joint Disease, Avascular Necrosis
- Trial name
- NCT03266874
- Where
- 5 sites in France, Germany and 2 more
- Volunteers
- 160 people
- Sponsor
- Zimmer Biomet
Diabetic Foot Ulcer
A Prospective, Randomized, Double-Blind Multicenter Study Comparing CDO Therapy to Standard MWT in the Treatment of DFUs
The purpose of this study was to evaluate the safety and effectiveness of Continuous Diffusion of Oxygen (CDO) therapy for the treatment of Diabetic Foot Ulcers.
- Trial name
- NCT01645891
- Testing
- CDO electrochemical tissue oxygenation system, Moist Wound Therapy
- Where
- 33 sites in United States
- Volunteers
- 146 people
- Sponsor
- Electrochemical Oxygen Concepts, Inc.
Foot Injuries and Disorders
Nutritional Supplements and Foot Surgery
This is a prospective randomized trial wherein participants will be assigned to NutraHeal™, NutraHeal Plus™, or standard of care for 1 week prior to foot surgery and 3 weeks after surgery.
- Trial name
- NCT05522179
- Testing
- NutraHeal, NutraHeal Plus
- Where
- 3 sites in United States
- Volunteers
- 46 people
- Sponsor
- NutraHeal
Chronic Ulcer of Leg or Foot, Diabetic Foot Ulcer
MAtrix Therapy for Hard-to-heal ChrOnic Wounds
CACIPLIQ20® is currently a class III CE marked medical device available in various European and non-European countries, and currently primarily used in managing hard-to-heal wounds.
- Conditions
- Chronic Ulcer of Leg or Foot, Diabetic Foot Ulcer, Arterial Ulcer, Venous Ulcer of Leg
- Trial name
- MATHCOW (NCT05170984)
- Testing
- CACIPLIQ20®
- Where
- France
- Volunteers
- 191 people
- Sponsor
- Organ, Tissue, Regeneration, Repair and Replacement
Diabetic Foot Ulcer
A Two-Part, Randomized Study of Dermacyte® Amniotic Wound Care Matrix
This is a multi-center, prospective, two-part, controlled study to determine the percentage of participants with complete ulcer closure of a target DFU at Week 12 following treatment with Dermacyte Matrix or SOC.
- Trial name
- NCT06444906
- Testing
- Dermacyte Matrix, Standard of Care (SOC)
- Volunteers
- 85 people
- Sponsor
- Merakris Therapeutics
Acute and Chronic Wounds, Pressure Ulcers
Clinical Evaluation of the SNaP Wound Care System
The purpose of this study is to assess the efficacy of design improvements of the Spiracur SNaP Wound Care System. This study prospectively evaluates the safety and efficacy of current and new design iterations of components of…
- Conditions
- Acute and Chronic Wounds, Pressure Ulcers, Trauma Wounds, Diabetic Foot Ulcers
- Trial name
- NCT01113658
- Testing
- SNaP Wound Care System
- Where
- 2 sites in United States
- Sponsor
- 3M
Deformity, Defect, Congenital
Observational Study on JuniOrtho Plating System for Deformities and Fractures Treatment in Lower Limb
Orthofix Srl put the JPS on the European market (2019) by the mean of a pre-market clinical evaluation made under the Medical Device Directive (MDD) requirements that were based on the analysis of the scientific literature of…
- Conditions
- Deformity, Defect, Congenital, Trauma
- Trial name
- JPS (NCT05245617)
- Testing
- JuniOrtho™ Plating System™
- Where
- Germany
- Volunteers
- 30 people
- Sponsor
- Orthofix s.r.l.
Anterior Cruciate Ligament Injury, Osteoarthritis
Safety and Efficacy Study of MSB-CAR001 in Subjects 6 Weeks Post an Anterior Cruciate Ligament Reconstruction
The purpose of this study is to evaluate safety and preliminary efficacy of MSB-CAR001 in subjects who have recently undergone an Anterior Cruciate Ligament Reconstruction
- Trial name
- NCT01088191
- Testing
- MSB-CAR001 Combined With Hyaluronan, Hyaluronan
- Where
- Australia
- Volunteers
- 17 people
- Sponsor
- Mesoblast, Ltd.
Diabetic Ulcers, Arterial Ulcers
Multicenter, Randomized, Non-inferiority Study to Compare the Performance and Safety of Debrisoft® Duo With Debrisoft® Pad in the Debridement of Wounds
The aim of this post market clinical follow up (PMCF) study is to confirm the performance of Debrisoft® Duo, to collect safety data regarding expected adverse events and to detect potential unexpected adverse events associated…
- Conditions
- Diabetic Ulcers, Arterial Ulcers, Venous Ulcers, Pressure Ulcers
- Trial name
- NCT07312513
- Testing
- two sided debridement pad, one sided debridment pad
- Where
- 5 sites in Poland
- Volunteers
- 100 people
- Sponsor
- Lohmann & Rauscher
Wound Heal, Wound Healing Disturbance of
Evaluating Safety and Biological Effect on Wound Healing of ILP100-Topical in Subjects With Diabetic Foot Ulcers
A randomized, double-blind, placebo-controlled, parallel, exploratory phase 2a study to evaluate safety and biologic efficacy on wound healing of ILP100-Topical in subjects with diabetic foot ulcers during 26 weeks with a 5-year…
- Conditions
- Wound Heal, Wound Healing Disturbance of, Wound Healing Disorder, Wound Healing Delayed
- Trial name
- NCT05608187
- Testing
- ILP100-Topical (emilimogene sigulactibac) 5x10^7 CFU/cm^2, ILP100-Topical (emilimogene sigulactibac) 1x10^9 CFU/cm^2
- Where
- 2 sites in Sweden
- Volunteers
- 1 people
- Sponsor
- Ilya Pharma
Diabetic Foot Ulcer, Pressure Injury
Evaluating Clinical Acceptance of a NPWT Wound Care System
Determine if use of the Medela Invia Motion NPWT system supports acceptable progress towards the goal of therapy when treating patients with a variety of wound types during the evaluation period.
- Conditions
- Diabetic Foot Ulcer, Pressure Injury, Pressure Ulcer
- Trial name
- NCT03670225
- Testing
- Invia Motion Endure
- Where
- United States
- Volunteers
- 10 people
- Sponsor
- Medela AG
Diabetic Foot Ulcers
Monochromatic Phototherapy on Diabetic Foot Ulcers
The purpose of this study is to evaluate the efficacy and safety of monochromatic phototherapy (Biolight®) on foot ulcers in diabetic patients, in comparison of placebo phototherapy as a complementary to standard diabetic foot…
- Trial name
- NCT00859599
- Testing
- Monochromatic phototherapy, Biolight®, Monochromatic phototherapy
- Where
- 7 sites in Sweden
- Volunteers
- 107 people
- Sponsor
- Biolight AB
Diabetic Foot Ulcer (DFU), Ulcer
Evaluating Autologous Platelet-Rich Fibrin Plasma for Chronic Diabetic Foot Ulcers
To prospectively evaluate the safety and efficacy of an Autologous Platelet-Rich Fibrin Plasma system when applied in conjunction with Standard of Care for management of chronic Diabetic Foot Ulcers.
- Conditions
- Diabetic Foot Ulcer (DFU), Ulcer, Wound Closure, Wound Management
- Trial name
- NCT07840378
- Testing
- PRFM, Standard of Care (SoC)
- Volunteers
- 55 people
- Sponsor
- Tiger Biosciences, LLC.
Knee Injuries and Disorders
AIR (Artificial Implant to Restore the Medial Meniscus Function)2 Clinical Investigation
The AIR2 Study is a multi-center, prospective, interventional clinical trial with the objective to evaluate the safety and performance of the Trammpolin® medial meniscus prosthesis.
- Trial name
- AIR2 (NCT05297175)
- Testing
- Trammpolin medial meniscus prosthesis
- Where
- 3 sites in Netherlands
- Volunteers
- 10 people
- Sponsor
- ATRO Medical B.V.
Foot Ulcer, Diabetic
A Comparison of an Investigational Dressing to Tegaderm Matrix Wound Dressing in the Management of Diabetic Foot Ulcers
The primary objective is to: Assess the effect of the Non-adherent study dressing to 3M Tegaderm Matrix Dressing with PHI technology on wound healing in patients with a diabetic foot ulcer.
- Trial name
- NCT01013792
- Testing
- Wound Dressing
- Where
- 6 sites in United States
- Volunteers
- 30 people
- Sponsor
- Solventum US LLC
Hip Fractures, Gait Disorders in Old Age
Clinical Study of the Effects of a SWalker II and VR for Hip Fracture Rehabilitation in the Elderly
This project is structured in two distinct phases. The first phase deals with the recovery of the hip fracture in the acute phase up to ambulation, and the second is understood as the continuation of functional improvement of…
- Trial name
- SWalker-VR (NCT06025981)
- Testing
- Preliminary Phase, Phase I - Early gait rehabilitation, Phase II - Maintenance gait function ( with VR)
- Where
- 2 sites in Spain
- Volunteers
- 100 people
- Sponsor
- Werium Assistive Solutions
Diabetic Foot Ulcer
Longitudinal Study of Chronic Wounds Using Novel Wound Measurement Technologies
An open, non-randomised longitudinal study of diabetic foot ulcers receiving standardised treatment, over a 16 week period conducted at out-patient level, utilising novel optical wound measurement technologies.
- Trial name
- NCT02967900
- Where
- United Kingdom
- Volunteers
- 15 people
- Sponsor
- Michelson Diagnostics Ltd.
Foot Ulcer, Diabetic
Pilot Study of the Safety and Clinical Efficacy of Topical Dermacyn™ Wound Care to Treat Mild Diabetic Foot Infections
To compare the rates of clinical success of Topical Dermacyn™ vs. Oral Levofloxacin vs. Combined therapy, in subjects with mild diabetic foot infections in non-ischemic ulcers.
- Trial name
- NCT00516958
- Testing
- Topical Dermacyn, Topical Dermacyn and Levofloxacin, Topical Saline and Levofloxacin
- Where
- 16 sites in United States
- Volunteers
- 65 people
- Sponsor
- Oculus Innovative Sciences, Inc.
Leg Ulcer, Pressure Ulcer (PU)
Performance and Safety of Mepilex® Up in Leg and Foot Ulcers and Skin Tears
This post-market clinical follow-up investigation is designed to evaluate the performance and safety of Mepilex® Up when used for the management of exuding ulcers and skin tears on the leg and foot.
- Conditions
- Leg Ulcer, Pressure Ulcer (PU), Skin Tears, Foot Ulcer
- Trial name
- NCT07782008
- Testing
- Mepilex® Up
- Where
- Sweden
- Volunteers
- 70 people
- Sponsor
- Molnlycke Health Care AB
Peripheral Vascular Disease
Safety/Feasibility Study of HBOC-201 in Amputation at/Below Knee From Critical Lower Limb Ischemia
The purpose of this study is to assess the safety and feasibility of HBOC-201 in increasing adequate wound healing in patients with severe peripheral vascular disease who are undergoing lower limb amputation.
- Trial name
- NCT00300040
- Testing
- Hemoglobin glutamer 250 - bovine, 6% Hydroxyethylstarch
- Where
- 5 sites in South Africa, United Kingdom
- Volunteers
- 16 people
- Sponsor
- Biopure Corporation